Egoropal

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Serious deficiencies were detected in aseptic manufacturing, creating a threat to product quality. A risk to patients' health or life cannot be excluded, particularly due to the parenteral injectable form of the medicine. Potential effects: infection, severe injection-related complications, lack of therapeutic efficacy.

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